CN100393314C - 一种利拉萘酯凝胶组合物及其制备方法 - Google Patents
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Abstract
利拉萘酯凝胶组合物及其制备方法，在凝胶组合物中含有活性物质利拉萘酯的助溶剂和润湿剂，从而改善利拉萘酯在凝胶中的溶解，制备分散均匀、稳定性良好的凝胶。
Description
技术领域
本发明涉及以利拉萘酯为生理活性物质的凝胶组合物及其制备方法。所说的利拉萘酯为角鲨稀环氧化酶抑制剂和细胞壁合成抑制剂，对治疗足癣、股癣、皮肤癣等真菌感染有良好药效。
技术背景
利拉萘酯通过抑制真菌细胞的角鲨稀环氧化反应，阻滞细胞构成成分麦角固醇的合成，从而发挥真菌活性。利拉萘酯的药理活性高，为托萘酯的8倍，抗皮肤癣菌的效果优于克霉唑，对毛发癣菌属、小孢子菌属和絮状表皮癣菌有特别的活性。但利拉萘酯几乎不溶于水，因而一般将其制备成为乳膏剂进行使用。由于乳膏剂的皮肤涂附舒适性差，而凝胶剂具有更易于涂展和洗除、无油腻感、同时能够吸收组织渗出液、不妨碍皮肤正常功能等优点，所以我们考虑将利拉萘酯制备成凝胶制剂。利拉萘酯在水中几乎不溶，药物在基质中溶解量低，不易分散均匀。因此，制备利拉萘酯凝胶剂应考虑改善利拉萘酯在基质中的溶解和均匀分散性。
本发明是基于改善上述技术中存在的问题而提出的，其目的是提供一种利拉萘酯凝胶剂的制备方法，制剂中所选用的添加剂为常用的药用辅料，无毒副作用，对皮肤无刺激。
本发明者为了达到上述目的，进行了反复深入的研究和试验，结果发现在凝胶制备过程中加入助溶剂、润湿剂等物质，可增大利拉萘酯在基质中的溶解，使得生理活性物质在凝胶中分散均匀，凝胶稳定性良好。
实施发明的技术措施
本发明涉及一种凝胶组合物及其制备方法，目的是制备治疗真菌感染的活性物质利拉萘酯凝胶。由于利拉萘酯几乎不溶于水，在凝胶基质中溶解量低，不易分散。因此，在该凝胶组合物中加入了对利拉萘酯有助溶和润湿作用的助溶剂和润湿剂，从而改善生理活性物质在凝胶中的溶解，制备分散均匀、稳定性良好的凝胶。
本发明的生理活性成分为利拉萘酯，用于治疗足癣，股癣，皮肤癣等真菌感染。组合物中利拉萘酯的用量为0.2-5重量％，优选1％-3％重量。
本发明中凝胶组合物的基质为卡波姆、羧甲基纤维素钠、甲基纤维素、交联聚丙烯酸钠、聚乙烯吡咯烷酮、明胶或它们的任意组合物，可采用改变上述物质浓度或调节pH等方法使上述基质构成的凝胶具有适宜的粘度。
本发明中为了增大利拉萘酯在水中的溶解，在制剂组合物中加入了助溶剂如丙二醇、异丙醇、甘油及它们的任意组合物等。组合物中助溶剂的用量为1-30重量％，优选3％-20％重量。
本发明中为了改善利拉萘酯在溶基质中的分散性，在凝胶组合物中加入了表面活性剂，如泊洛沙姆、十二烷基硫酸钠、聚山梨醇、聚氧乙烯脂肪酸酯等润湿剂。在活性物质加入基质前，可将其溶于润湿剂的水溶液中进行分散乳化，再加入到凝胶基质中搅拌，分散。组合物中润湿剂的用量为0.05-10重量％，优选0.2-2重量％。
本发明在制剂组合物中除加助溶剂和润湿剂等物质外，还可以加入其他辅料，如氢氧化钠，乙二胺四乙酸二钠，羟苯乙酯等。
用上述组分和方法制备的利拉萘酯凝胶具有以下优点：凝胶细腻，易于涂展，活性物质分布均匀，稳定性好。
实施例
下面结合实施例对本发明作进一步详细说明。
结合实施例具体说明本发明，但并不局限于下述的实施例。其中“％”是指“重量％”。
实施例1
制备工艺：
卡波姆934搅拌加入乙二胺四乙酸二钠的水溶液中，待完全溶解后，加入利拉萘酯、波洛沙姆、丙二醇和水的混悬液。在快速搅拌的情况下，加入氢氧化钠溶液、混匀，得利拉萘酯凝胶。
实施例2
制备工艺
卡波姆934搅拌加入乙二胺四乙酸二钠的水溶液中，待完全溶解后，加入利拉萘酯、十二烷基硫酸钠、异丙醇和水的混悬液。在快速搅拌的情况下，加入氢氧化钠溶液、混匀，得利拉萘酯凝胶。
实施例3
制备方法
卡波姆934搅拌加入乙二胺四乙酸二钠的水溶液中，待完全溶解后，加入利拉萘酯、聚氧乙烯(40)硬脂酸酯、甘油、羟苯乙酯和水的混悬液，在快速搅拌、混匀，得利拉萘酯凝胶。
如上述实施例制备的凝胶，含有助溶剂，药物在基质中溶解度较大；药物经润湿剂乳化，药物在基质中分散均匀，稳定性好。
Claims (8)
1.一种利拉萘酯凝胶组合物，其特征在于，包括按重量计0.2～5％的利拉萘酯、1～30％的助溶剂、0.05～10％的润湿剂、0.2～3％的凝胶基质，所述助溶剂选自丙二醇、异丙醇、甘油或者它们的任意混合物；所述润湿剂选自泊洛沙姆、十二烷基硫酸钠、聚山梨醇、聚氧乙烯硬脂酸酯或它们的任意混合物。
2.如权利要求1所述的组合物，其特征在于，所述利拉萘酯的含量为1～3％。
3.如权利要求1所述的组合物，其特征在于，所述助溶剂的含量为3～20％。
4.如权利要求1所述的组合物，其特征在于，所述润湿剂的含量为0.2～2％。
5.如权利要求1所述的组合物，其特征在于，所述凝胶基质选自卡波姆、羧甲基纤维素钠、甲基纤维素、交联聚丙烯酸钠、聚乙烯吡咯烷酮、明胶或者它们的任意组合物。
6.如权利要求1所述的组合物，其特征在于，所述凝胶基质为卡波姆。
7.如权利要求1所述的组合物，其特征在于，所述凝胶基质的含量为0.5～2％。
8.如权利要求1所述的组合物，其特征在于，所述组合物还含有络合剂乙二胺四乙酸二钠、pH调节剂氢氧化钠或防腐剂羟苯乙酯。
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| CN103156815A (zh) * | 2011-12-14 | 2013-06-19 | 西安泰科迈医药科技有限公司 | 一种用于白癣病的分散片制剂及其制备方法 |
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| EP0715856A1 (en) * | 1994-05-06 | 1996-06-12 | Toko Yakuhin Kogyo Kabushiki Kaisha | Keratin-storable antifungal composition for external use |
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|---|---|---|---|---|
| EP0715856A1 (en) * | 1994-05-06 | 1996-06-12 | Toko Yakuhin Kogyo Kabushiki Kaisha | Keratin-storable antifungal composition for external use |
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